TAXAJ

Drug License (Retail/Wholesale) Registration

A drug License is mandatory to do the Drugs & Cosmetics business in India. Drugs & Cosmetics Act, 1940, prescribes the Act for of India. This Act consolidates all the laws relating to drugs & cosmetics in India, establishing the Drugs Control Department. In 1964, an amendment was brought to the Act to include Ayurvedic & Unani drugs under it. As there is a variety of Drug licensing, a particular business entity may require different drug licenses based on their Business. You may contact TAXAJ for consultancy on it. If a business operates in more than two states, it has to obtain a drug licence in each particular state where Business is being carried on. Drug licence is location-specific. If drugs are sold or stocked for sale from multiple places, then an application shall be made disclosing all the places, and a license shall be issued in respect of each such place showing them as Additional place of Business except migrant vendors. Once the licence is granted, it must ensure quality compliance in the drug business at all the time during the Business. All the records /registers /Forms must be maintained in the manner specified by the licensing authorities. Authorities must be kept informed of all the changes or modifications in the business activities.
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About This Plan

Avail various benefits under the scheme ? Apply for Drugs License Registration with TAXAJ

Created by potrace 1.15, written by Peter Selinger 2001-2017

Timeline

It usually takes 45 to 60 working days.

Buy Now
Services Covered
Who Should Buy
How It's Done
Documents Required
Services Covered

  • Drafting documents
  • Filing of forms with Authorities
  • Documented Follow-up
  • Business hours - CA support
Who Should Buy
  • Any business entity or Individual
How It's Done

    • Applicant has to obtain user ID and Password by giving request letter in person with the details of the firm.
    • All the documents should be scanned in 100 dpi and black and white and then should be uploaded using the said ID and Password at space provided for the purpose. All the information is filled precisely for respective application and then e-send the application. The licensing authority may ask for any other specific documents if required.
    • You will then need to follow-up with the government department for an update on your application. In case of rejection of your application for incomplete information, the fees once paid will be forfeited by the government.
    • The government department will take 45-60 working days to completely review your application and approve the same. Else, you can hire TAXAJ for getting the Drug license for you. We get license issued in 98% of our cases and save our customers from all the government hassles.
Documents Required
  • Constitution of the entity, Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed, LLP agreement in case of partnership and LLP.
  • ID proof of partner/director/proprietor.
  • Documents related to premises – Copy of ownership documents of property or rental agreement as the case may be.
  • Site plan and key plan of the premises.
  • Copy of Board resolution permitting obtaining of a license.
  • Proof of availability of storage space as cold storage, refrigerator, etc.
  • Copy of challan as a proof of depositing fee.
  • Affidavit regarding non-conviction of proprietor/partner/director and the firm.
  • The affidavit from the registered pharmacist/competent person.
  • For a pharmacist at a retail sale:
    • Proof of qualification
    • Registration of local pharmacy council
    • Appointment letter
  • For a pharmacist at a wholesale sale:
    • Proof of qualification
    • Experience certificate
    • Appointment letter

Wholesale Drugs License made easy with Team TAXAJ!

Meaning of Drugs

Section 3(b) of the Drugs and Cosmetics Act,1940 defines “drug” to include all medicines and devices for the use of human beings or animals internally or externally, and all substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body for the purpose of repelling insects like mosquitoes; it also includes all substances that can be used for the destruction of insects and all components of a drug – like empty gelatin capsules. The definition was amended in 1964, to include Ayurvedic and Unani Drugs.

Types of Drug License

Looking at the definition of “drug”, the pharmaceutical business in India requires the following types of licenses:

  • Manufacturing License– License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.
  • Sale License – License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License
    • Wholesale License – A drug wholesaler must obtain a wholesale licence. Wholesale means the sale of the drug to a person/retailer to further sell it.
    • Retail License – A retail license is required for the retail sale of drugs. A retail sale means the sale of drugs or cosmetics for the consumption of the end consumer. Retailers can sell it to a dispensary, hospital, educational, medical, or research institute. Retailers engaged in pharmaceuticals, cosmetics, stand-alone pharmacists, ayurvedic shops, etc need this license.
  • Loan License – License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee.
  • Import License – License issued for the import of drugs.
  • Multi-Drug License – License issued to businesses that own pharmacies in multiple states with the same name.

   Condition for Obtaining Drug License

  • Pharmacist/ Competent Individual: The pharmacist must be qualified in the case of a retail business. In the case of a wholesale business, the individual must be a graduate with 1-year experience or an undergraduate with 4 years experience.
  • Space Requirement: The other important requirement is space, that is the area of the pharmacy/unit. For both wholesale and retail licenses the area of the pharmacy/unit should be 15 square meters. In the case of a retail and medical shop, it should be 10 square meters. The clear height of the sales premises shall be as per the guidelines laid down under the National Building Code of India, 2005.
  • Storage Facility: The other important requirement is storage facility since some drugs require to be stored in low temperatures, refrigerators and air conditioners are a must.
  • Technical Staff: The retail pharmacy staff must be experienced with in-depth knowledge. The staff of the wholesale pharmacy must be a graduate with a minimum of 1-year experience or an undergraduate having four years of experience.

Application for a Drug License

The following are the steps to be taken for obtaining the drug license:

  • The applicant must apply online for the license as per the line of business, for which he/she must have a valid email id and contact number.
  • The next step is to keep all the documents updated.
  • Next is to upload the documents and the form along with the applicable fees.
  • Upon completion of the online process, an inspector will visit the site and verify the validity of documents.
  • If all the above steps have been duly complied with, the authority will issue the drug license.

List of Application Forms

Sr. NoForm NoPurpose
1Form 19Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those specified in Schedule X.
2Form 19AApplication for granting or renewing a restricted license to sell, stock, exhibit or offer for sale, or distribute drugs by retail via dealers who don’t engage the service of a qualified individual.
3Form 19BApplication for license to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines.
4Form 19CApplication for grant or renewal of a [license to sell, stock, exhibit or offer for sale, or distribute] drugs specified in Schedule X.
5Form 24Application for either the grant of a license or for the renewal of a license or to manufacture for sale or for distribution of drugs other than those which are specified in [Schedule C, C (1) and X].
6Form 24AApplication for either the grant of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X.
7Form 24BApplication for grant or renewal of a licensee to repack for sale or distribution of drugs, being drugs other than those specified in Schedule C and C (1) excluding those specified in Schedule X.
8Form 24CApplication for the grant or renewal of a license to manufacture for sale [or for distribution] of Homoeopathic medicines or a license to manufacture potentized preparations from back potencies by licensees holding a license in Form 20-C
9Form 24FApplication for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedule C and C(1).
10Form 27Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X

Frequently Asked Questions

What are the types of drug businesses that require a drug license?

All types of drugs or cosmetics businesses that fall under the Drugs and Cosmetics Act, 1940, are required to obtain a drug license before starting/establishing a drug or cosmetics business. The Drugs and Cosmetics Act covers all drugs businesses, including allopathic, homoeopathic, ayurvedic, Siddha or Unani drugs. 

What are the drugs included under the Drugs and Cosmetics Act, 1940?

The drugs included under the Drugs and Cosmetics Act are as follows:

  • All medicines for external or internal use of animals or human beings and all substances intended to be used for or in the treatment, diagnosis, prevention, or of any disease or disorder in animals or human beings, including preparations applied on the human body for repelling insects like mosquitoes.
  • Substances (other than food) intended to affect the function or structure of the human body or intended to be used to destroy insects that cause disease in human beings or animals, as may be specified by the Central Government by notification in the Official Gazette. 
  • All substances intended for use as components of a drug, including empty gelatin capsules.
  • Such devices intended for external or internal use in the treatment, diagnosis, prevention, or mitigation of disorder or disease in animals or human beings, as may be specified by the Central Government by notification in the Official Gazette.
Is the drug license and a pharmaceutical business license the same? 

Yes. The drug license is also known as a pharmaceutical license. A drug license is required for all businesses involved in distributing pharmaceutical and medicines supplements. 

I have a drug license in Bangalore. Do I need to obtain another drug license to sell my drugs in Chennai?

Yes. When a drug business has an operating unit in two or more states, it has to obtain a drug license separately for each state in which it carries the business. The drug license registration is location-specific. Thus, if the drugs are sold or stocked for sale and distribution at more than one place, the application should be made to every state, and a license will be issued regarding each place except for migrant vendors.

Who are the regulatory authorities that issue drug licenses?

The drug controlling authority specified under the Drugs and Cosmetic Act provides the drug licence. The drug controlling authorities (regulating authorities) are as follows:

  • State Drugs Standard Control Organisation (SDSCO) – Issues licenses for the sales, distribution, and manufacture of drugs regulated by the state authorities.
  • Central Drugs Standard Control Organisation (CDSCO) – Responsible for approving the newly made drugs and clinical trials of drugs. It also controls the quality of the imported drugs and coordinates with the SDSCO.
  • State Drug Controlling Authority with approval by the Central License Approving Authority – Issues licenses for establishing blood banks and their components and products like Vaccines, Sera, etc.
  • Department of Ayush – Issues licenses for ayurvedic, Unani, Siddha, homoeopathic and herbal products for cosmetic and medical use.
What is the validity of a drug license?

A drug licence is valid for five years unless cancelled and suspended by the drug department. 

What happens to the drug licence if there is a change in premises?

When there is a change in premises, the drug license for the old premises has to be surrendered, and the drug business owner has to apply for a new licence for the new premises. 

Do importers of drugs need a wholesale license?

Yes, the importers of a drug(s) must obtain both an import license and a wholesale licence to sell imported drugs within India.